Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study evaluates the reduction of lymphedema and its complications in obese women treated with a muscle training and weight loss program as well as the improvement body composition, muscle strength, quality of life and neurocognitive function, compared to a conventional treatment control group.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients older than 18 years and under 80 who have lymphedema diagnosed according to the truncated cone formula (increase of \> 200 ml with respect to the contralateral) and are referred to Rehabilitation for treatment.

• Having completed the chemotherapy and radiotherapy treatment at least 6 months prior to randomization.

• Not having received manual lymphatic drainage in the 2 months prior to the intervention.

• BMI \> 25 y \< 40 kg/m2.

• Signature of informed consent.

Locations
Other Locations
Spain
Hospital Regional Universitario de Málaga
Málaga
Time Frame
Start Date: 2021-05-17
Completion Date: 2024-05-17
Participants
Target number of participants: 100
Treatments
Experimental: Exercise and nutritional program
Intervention group that receives supervised exercise and weight loss program based on individual and group intervention with Mediterranean diet and substitute for a daily meal (non-mandatory), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.
No_intervention: Control Group
Control group will receive recommendations for aerobic unsupervised exercise 150 min per week, standard dietary recommendations (Mediterranean diet pattern and 1800 Kcal diet), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.
Related Therapeutic Areas
Sponsors
Leads: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

This content was sourced from clinicaltrials.gov